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NCT Number: NCT07395128

Lateral Plantar Artery Embolization For Plantar Fasciitis

The goal of this clinical trial is to learn if lateral plantar artery embolization using Lipiodol can safely and effectively treat chronic heel pain due to plantar fasciitis in adults aged 25 to 80. The main questions it aims to answer are:

Does this procedure successfully reduce chronic heel pain as measured by the Visual Analog Scale (VAS) over 12 months?

How safe is the procedure, specifically regarding the frequency of serious medical problems or adverse events related to the device?

Participants will:

Undergo a minimally invasive procedure where a doctor uses a small tube (catheter) to inject a temporary blocking agent (LipioJoint) into specific blood vessels in the foot.

Receive a phone call one day after the procedure to check for early side effects.

Participate in four follow-up telehealth visits over the course of one year (at 1, 3, 6, and 12 months).

Complete pain intensity surveys (VAS) and report any changes in their use of other therapies or medications during these visits.

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Key information

Conditions

Plantar Fasciitis, Chronic Fasciitis Fasciitis, Plantar Foot Diseases Musculoskeletal Diseases Plantar Fasciitis

Age range

25 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Joint and Vascular Institute

Libertyville, Illinois, 60048, United States

Location status: Recruiting

Location contact

Layth Alkhani

CONTACT

[email protected]

847-584-3959

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 25 years
  • Subject provides written informed consent
  • Patient with Plantar Fasciitis refractory to 3 months of conservative management
  • Self reported pain of at least 4/10 on visual analog scale (VAS)
  • Non-surgical candidate/looking to avoid surgery

Exclusion criteria

  • Heel pain caused by acute fracture, recent trauma, inflammatory conditions, muscle/ligament injury, and etiologies related to bone mineral density.
  • Steroid injection in the last 90 days from the embolization procedure
  • Known severe allergy to Lipiodol and/or iodinated contrast media
  • Diagnosis of peripheral arterial disease affecting the lower extremities
  • Pregnancy or breastfeeding
  • Anticoagulation or irreversible coagulopathy
  • GFR <45 or Serum creatinine > 2.0 mg/dl
  • Type 1 Diabetes Mellitus

Treatment and study plan

Lipiodol

Device

Participants will receive a transcatheter arterial embolization of the lateral plantar artery branches. The intervention involves the selective catheterization of the calcaneal branches under fluoroscopic guidance using a microcatheter. A mixture of Lipiodol (a transient liquid embolic agent) and iodinated contrast media is injected until an endpoint of "near stasis" is reached. A maximum of 5 mL of Lipiodol will be used per procedure. This intervention specifically targets the hypervascularity (neovascularization) associated with chronic plantar fasciitis to alleviate pain and reduce inflammation.

Primary outcomes

  1. Pain Change

    Time frame: Baseline to 12 months

    Pain - measured via VAS at baseline, 1-month, 3-month, 6-month, and 12-month follow-up

  2. Safety (rate of adverse events)

    Time frame: Baseline to 12 month follow-up

    Safety - Percentage of subjects without serious adverse events related to the medical device

Study contacts

Contact information is provided by the study sponsor or research team.

Layth Alkhani

CONTACT

[email protected]

847-584-3959

Sponsors and collaborators

Lead sponsor

Joint & Vascular Institute

Industry

Registry information

Official study title

Lateral Plantar Artery Embolization to Treat Pain Chronic Heel Pain Due To Plantar Fasciitis A Pilot Study to Assess Feasibility

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 9, 2026
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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